Human health and patent law

The deleteriousness of TRIPS, in relation to health and social justice, cannot be wished away by Parliament since Right to Life, a basic feature and constitutional guarantee, cannot be truncated or trampled upon. So too social justice and right to development in its distributive dimension.

DEAR life in good health and free from disease is the foremost human right and is a constitutional fundamental. The humbler the Indian human, the higher the state's duty to protect the person. In this perspective we may have to examine the impact of TRIP S (Trade-Related Intellectual Property Rights) Agreement on Indian corpus juris vis-a-vis the right to life guaranteed under Article 21 of the Constitution, read with Article 14.

Public health laws, national drug policy and the patent system are intensely inter-related. This was explained by Prime Minister Indira Gandhi while speaking at the World Health Assembly in Geneva on May 6, 1981. In her words: "Affluent societies are spending vast sums of money understandably on the search for new products and processes to alleviate suffering and to prolong life. In the process, the drug manufacture has become a powerful industry." She added, on the patent system: "My idea of a better ordered world is one in which medical discoveries would be free of patents and there would be no profiteering from life or death." In this historic session, the participating countries unanimously adopted a resolution for "Global Strategy on Health for All". Since then there have been laudable contributions by science and technology to tackle successfully many health problem areas. While there is a substantial unfinished agenda on the health front, new and formidable challenges have been thrown up by an unequal treaty on all-pervasive economic and social aspects by the Final Act embodying the results of the Uruguay Round negotiatio ns. In particular, the TRIPS agreement is the most contentious part of the Final Act. The aim of this agreement is to enforce globally tough standards in respect of several forms of intellectual property, which include patents, trade marks, protection of undisclosed information, and so on, forgetting the goals expressed by Indira Gandhi in regard to freeing of medical discoveries from the patent system. (B.K.Keayla) Going to the fundamentals, what is a patent? A patent is a monopoly right granted by a state to a person to exploit and benefit from the invention patented by him for a particular period. Thereafter, it passes into the public domain. According to Justice Rajagopala Ayyangar's report submitted in 19 59, which report constitutes the basis for the Indian Patents Act, 1970, "The theory upon which the patent system is based is that the opportunity of acquiring exclusive rights in an invention stimulates technical progress in four ways: first, that it en courages research and invention; second, that it induces an inventor to disclose his discoveries instead of keeping them as a trade secret; third, that it offers a reward for the expenses of developing inventions to the stage at which they are commercial ly practicable; and fourth, that it provides an inducement to invest capital in new lines of production which might not appear profitable if many competing producers embarked on them simultaneously. Manufacturers would not be prepared to develop and prod uce important machinery if others could get the results of their work with impunity." To the same effect is the decision of the Supreme Court in Vishwanath Prasad v. Hindustan Metal Industries (1979 (2) SCC 511). (Justice Jeevan Reddy)

In a cultural milieu where "knowledge is free", and is transmitted from generation to generation as a duty, it is incongruous to convert discoveries into "cash and carry" vulgarity but that is the perversion under pressure from Western Big Business. "Int ellectual Property Rights" conceptually belongs to this moneymanic bigotry and TRIPS is the parent of this morally indefensible but virtually glorified anathema. Even so, in human affairs, minor adjustments, without forsaking fundamentals, may be necessa ry for peaceful co-existence. Even the TRIPS text partially acknowledges this aspect.

It is ironic but interesting to recall Thomas Jefferson's words:

"If nature has made any one thing less susceptible than all others of exclusive property, it is the action of the thinking power called an idea... No one possesses the less, because every other possesses the whole of it. He who receives an idea from me, receives instruction himself without lessening mine; as he who lights his taper at mine, receives light without darkening me." In Jefferson's vision, there are no barriers to the acquisition of knowledge. Nobody owns it, everybody partakes of it - and th e world becomes richer. Alas, his country is the most venal violator of this value.

Our cultural cornerstone, the Rigveda mandates: "Let noble thoughts come to us from every side." Patenting intellect or its products is sacrilegious and a social outrage.

The trouble with the law is that it does not differentiate between the incentives needed to invest in different kinds of technologies. It accords as much protection to an idea thought up in the bath as to a drug that may have taken many years and hundred s of millions of dollars to move from conception to marketplace. Even Jeff Bezos, founder of the Internet retailer Amazon.com and the holder of several business-method patents, has suggested in an open letter posted on the Internet that software and busi ness-method patents should have a shorter life than other patents - say, three to five years. The deleteriousness of TRIPS, in relation to health and social justice, cannot be wished away by Parliament since the right to life, a basic feature and constitutional guarantee intractable by parliamentary majority, cannot be truncated or trampled upon. So too social justice and right to development in its distributive dimension. While in form and phraseology the World Trade Organisation (WTO) - the successor to the General Agreement on Tariffs and Trade (GATT) - was set up to ensure more free trade, in actual fact the TRIPS Treaty catalyses monopolies, inhibits competition and freezes the initiatives of Indian scientists and technologists in producing cheaper and better products through more facile and finer processes. The TRIPS Agreement, in its re strictive provisions, sabotages developmental objectives and creative quantum leaps by countries like India which have intellectual potential and actual successes in the field but suffer from inhibitions through TRIPS taboos and GATT handcuffs. The specious plea that foreign technology will flow into India if product patent is legalised, is a patent unreality. Wisely, the Indian Parliament currently grants only process patents although hasty, harmful mutations are under way. Under TRIPS, monopolies are strengthened and the prices of pharmaceuticals are apt to jump, leaving the poor and their Right to Life to fatal fate! Domestic enterprises have to encounter unequal competition on an uneven playing field with gargantuan corporations wit h their publicity power, glamour and clout. In short, the interests of Indian consumers and producers will be a casualty if the patent law of India, so carefully crafted, is to suffer mayhem by parliamentary self-infliction under exotic pressure and/or a n insufficient understanding of the portents if products of all kinds are thrown open for patentisation. "Health for all", an undertaking made by India internationally, will be a victim of surrender to TRIPS pressure. Beware! The poor shall not spare but would rather dare in despair.

The Union government is moving the new amendments apparently under the TRIPS Circean spell, although I hold the view that by a people-oriented interpretation and national resistance, based on grim realities, we can salvage a substantial portion of our existing statute. Let me recall Articles 7 and 8 of the TRIPS Agreement:

Article 7 Objectives - The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of te chnological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations. Article 8 Principles - (1) Members may, in formulating or amending their national laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-econ omic and technological development, provided that such measures are consistent with the provisions of this Agreement. (2) Appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right-holders or the resort to practices which unreasonably restrain trade or adverse ly affect the international transfer of technology.

Justice B.P. Jeevan Reddy, in a lucid lecture, explains a vital difference between Process Patent and Product Patent:

"Patents are of two kinds - product patents and process patents. If the result of a new process is a new article or a better article or a cheaper article than that produced by an old method, that process is patentable and is called the process pat ent. In other words, a new and alternative method of arriving at the same result, irrespective of whether that result is better or cheaper, is patentable. As against this a product patent means the grant of a monopoly right to produce that product which necessarily means preventing any other person from producing the same product, whether improved or otherwise, and even by adopting a different or new process, for the period of patent. The Rajagopala Ayyangar Committee advisably and wisely, if I may say so with respect, recommended for providing legal protection only to process patents and not to product patents."

The battle between process patent and product patent can be largely eliminated by a stiff Indian stance. Value of life, law and order, moral standards and cultural heritage are inviolable and non-negotiable. Whole rural communities will br eak the amended patent law when confronted by starvation and death as a consequence. Trips versus Terrorism is apt to be the dialectical contradiction. The choice is obvious. The 1970 Act, with humanist concern, makes compassionate exclusions. Let me quo te Justice Jeevan Reddy:

"While defining the expression 'medicine or drug' in such expansive terms, the Act took care to exclude several matters from the purview of "invention". Section 3 sets out matters which cannot be treated as inventions. Among the matters so excluded in S ection 3 are "(h) a method of agriculture or horticulture; (i) any process for the medicinal, surgical, curative, prophylactic or other treatment of human beings or any process for a similar treatment of animals or plants to render them free of disease o r to increase their economic value or that of their products. Almost 90 per cent of the drugs and medicines produced in the world are produced by about ten multinational corporations in the world located in the USA, Germany, Switzerland, the U.K. and pro bably the Netherlands. These multinational companies say that they are constantly inventing new medicines to treat human and animal ailments and plant diseases. They say that they have to and have been spending billions of dollars on research, that only a few of the products into which research is conducted prove to be successful from a commercial point of view and that to enable them to carry on this research activity it is essential that they should be allowed to have a patent for the product invented by them so as to reimburse themselves for the cost of research undertaken by them. Since their products are sold all over the world, they prefer uniform patent laws, that is, product patents, modelled upon the patent laws of the advanced countries. In s hort, they want to impose product patents on all those countries where it does not exist - and India is one of them. "At this juncture, I may point out to a popular but true example illustrating the consequences of the product patent system and the process patent system. Glaxo is one of the multinationals. It manufactures, inter alia, 'zenetac', an antacid medic ine. It manufactures the said medicine in India, in the U.K. and in the USA. A ten-tablet strip of zenetac costs in India a little above seven rupees, in England it costs more than three hundred rupees and in the USA it costs more than eight hundred rupe es. Even in Pakistan it is sold for around one hundred and twenty rupees. You may immediately ask why is Glaxo selling the very same medicine in India at such a cheap price and why is it selling the same in USA at more than hundred times the price in Ind ia. That is because in India we do not have product patent. The absence of a product patent has enabled any number of Indian pharmaceutical companies to manufacture antacid tablets with the same properties by different processes, processes which are both cheaper and, may be, better." Product patent is a death sentence on indigenous pharmaceuticals. The blunder of signing the Uruguay Round (as later conceded by some Ministers) is an anti-people sell-out. One thing is certain. Any product, to be patentable, needs the triple qualities o f (a) novelty (previously unknown to the public) (b) non-obviousness (containing sufficient innovativeness to merit protection) and (c) industrial applicability for usefulness. By one broad stroke, all ayurvedic drugs, adivasi recipes, alternative native medicines, naturopathy, magnetotherapy and yoga therapy, from Charaka and Susruta and Patanjali downwards, familiar in various parts of India and therefore no novelty at all, can be out of the pale of patents. Minimal changes which have nothing to do wi th the core of it, but impart glittering appearance, attractive packing and sexy advertising magic, cannot be treated as establishing novelty. Ultra-modern manipulation of ancient vintage Indian medicine cannot be fobbed off as patentable merely by using dazzling brand name baloney. Already American pharmaceuticals are taking patents for neem, tulasi, gooseberry and what not? This is a fraud and a scam, not legally permissible.

Dr. Vedaraman, a super-specialist in this legal branch, suggests that the section 2 (I) "Invention" has been understood to mean "an invention which must involve an important technical advancement of considerable economic significance" in relation to prior art or the matter existing in the public domain on the date of application. Tweedledom to tweedledee is too trivial an innovation.

Process patents are already in our statute although, philosophically speaking, knowledge is universal and free. Advance of civilisation or march of science is not decided by rushing to patents offices. It is doing violence to cultural values to me asure prosperity by a profusion of patents. Even assuming that intellectual property (a divine gift) is monopolisable, larger opportunities to make products in the public interest must prevail over vulture-culture greed and profit through patents, sacrif icing humanitarian considerations. Life-saving methods must not be market-controlled commodities or services. The worth of the human person is so high that the maximum enlargement of easy availability of such products and processes must be legally permis sible.

Viewing TRIPS from this mega-benevolent angle, Articles 7 and 8 can be liberalised hermaneutically and thereby we may drop the injurious amendments to the Patents Act. When a patent-holder monopolises and practises exclusivity and secrecy so as to contra dict "the promotion of innovation", he obstructs dissemination of technology and thus violates Article 7. His operation is not conducive to social and economic welfare. So a specific provision against patents whose result will be a socio-economic barrier to India's research and discovery of new pharmaceutical advances is fair. The West cannot claim legitimacy for a stranglehold on Indian progress, using patent right as an iron curtain. Law is for life, science is for "man" and the dignity and wor th of the human person shall not suffer "patent servitude". Let us not forsake United Nations fundamentals.

Article 8 (1) quoted above has great potential for whittling down the scope for patents which involve life, health and social development vital for the people so pervasively poor as Indians, stricken with ill-health and nutritionally miserable. To explo it sickness and peril to life merely to pamper monopolists is to betray constitutional mandates and global human rights. We cannot allow MNC quislings in Bharat. Ours is a socialistic pattern of society. We have high infant and maternal mortality, famine conditions and fatal syndromes, to cure which medical supplies are an urgent necessity across the nation. But where is the will to resist predator-corporate power and redeem the tryst with the nearly five hundred hungry million humans? Our patriotic par liamentarians will (must) decline to outrage the conscience of a sixth of mankind through nescience or pusillanimity and invite rebellion against MNC tyranny.

Members (like India, for instance) "may, in formulating or amending their national laws adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technol ogical development". This is TRIPS text. Given semantic sympathy, we can press everything needed to protect and preserve public health, nutrition as well as public interest and technological development, and make drugs to remedy the proliferating maladie s victimising the masses and thus save the 1970 Act almost in toto as falling within the permissive spaces of TRIPS. Of course, the battle raging round product versus process patent remains, although I take the view that, having grave regard to th e grim state of health, fatal diseases, prevalence of penury and inviolable Buddha-Gandhi tradition of compassion, the rejection of restrictive product patent is reasonable. The Preamble and basic features of the Constitution bind and command this step. Abuse of intellectual property rights by rights-holders and unreasonable restraint on trade and other adverse ploys affecting national concerns can be checked under Article 8 (2). Why not dare and do, sustaining the present law, instead of amendme nts being made to suit corporate palate and pocket?

Article 27 (2) gives scope for saving our patent law from corporate claws. The text reads:

"Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to av oid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by domestic law."

Let me present a set of interrogatories:

Patents in India for goods manufactured outside and imported? Sky-high prices for drugs and commodities needed by poor people in large numbers in our Socialist Republic without state control? Over-publicised goods with erotically app ealing and addictive methodology to create craving? Manufacture of vicious but tempting consumer items - the Coke craving and Mcdonalds magic which harm health in the long run - may become "the opium of the people", eventually leading to cancer deaths, s uicides, bankruptcies, divorces, social disorder, morally degenerative and traditionally obnoxious merchandise, made and sold with malignant monopoly, creating law and order problems, violation of hygiene and the like? No, never! These exotic goods an d services are bete noire for the composite cultural heritage of India (Article 51 A) and incompatible with social justice basic to our Constitution. To grant a monopoly by way of patent within India, without obliging the producer to manufactu re within our country but to import and exploit the market, free from competing Indians, is egregious, absurd and anti-Indian. The concession of patent must be conditioned by the obligation to make the goods here. Let me cite Sir Robert Ree d:

"Nothing can be more absurd or more outrageous than that a foreign patentee can come here and get a patent and use it, not for the purpose of encouraging industries of this country but to prevent our people (from) doing otherwise what they would do. To a llow our laws to be used to give preference to foreign enterprise is to my mind ridiculous."

To manufacture cheap outside, import and sell at any price in our market preventing by law indigenous producers is almost a definition of colonisation by a foreign power entering India, forbid Indians making the goods but offer a monopoly market. Why concede this dog-in-the-manger strategy? This is a textbook case of the violation of Article 19 (1) g and 19 (6) of the Constitution. This stratagem, if legislatively approved, is a shock and shame and proof of conquest by patent. Articles 14 (equal protection of the law), 19 (right to any trade or business) and 21 (right to life in good health) stand stultified if such glaring inequality between Indian products (denied patent) and foreign import of any commodity granted exclusive selling rig hts with no special benefit to the Indian consumer. This is gross inequality writ large, arbitrary, with no rational nexus to the wellbeing of "We, the People of India... (Article 14).

Similarly, Article 19 is unreasonably transgressed. To refuse the non-patentee the right to manufacture the same product, the restriction must be justified constitutionally by reasonable grounds relatable to public interest. For the surrender of a non-pa tentee's Article 19 rights, what is the substantial public interest for Indians? No other ground save that MNC Might is Right. And "the most unkindest cut of all" is that by the grant of patents on even agriculture, pharmaceuticals and essential items ne cessary for the life of the community, Article 21 - the right to life, health, shelter - is frustrated.

Can free trade warrant trading away our freedom? But that is the result if the bill goes through as introduced.

However, by interpretative enlargement, Article 27(2) of TRIPS can be turned to India's advantage by exclusion from patentability any invention on grounds of "ordre public or morality." Non-patentability, so as to protect human, animal or plant li fe or health or to avoid prejudice to the environment, is valid under TRIPS. So a large area of manufacture can be kept out of bounds for patents, having regard to Hindu religious sentiment of Vedic vintage, with its worshipful concern for plants and ani mals, ecology and environment.

The government has moved the Patents Amendment Bill proposing to amend the Patents Act 39 of 1970 which, in the past, has been a major success in the legislative field for the promotion of the health of the people and the advancement of industry and agri culture. Assuming that some amendments are necessary, how far do the amending provisions stand the scrutiny of reasonableness and constitutional compatibility?

TRIPS must be read down as its broad objective is:

1. "to ensure that developing countries... secure a share in the growth in international trade commensurate with the needs of their economic development". To quote a statement made by the government in an international forum, "developed countries have ut ilised the WTO system to obtain legitimacy for their own protectionist policies", and they continue with their trade barriers. So I urge Parliament to reject WTO super-sovereign hold. 2. Members may, in formulating or amending their national laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and "technological development, provided that such measures are consistent with the provisions of this Agreement". We have room for interpretive benevolence. A report produced for the United Nations Development Programme (UNDP) says that TRIPS was signed before most governments and people understood the social and economic implications of patents. Third World TRIPS must be protected: Union Law Minister (Th e Hindu Business Line, February 12, 2000). The Minister stated that the rights of the poor and developing countries must be safeguarded while enforcing TRIPS laws. He also added that "although India was taking to a free market society, India had a co nstitutional obligation to provide assistance to the poor". WHO DAP Series No.7 (Health Economics and Drugs) has recommended that any drug on the WHO Model List of Essential Drugs should be the object of a compulsory licence for public health reasons. The WHO report also states that a certain number of 'sensitive ' provisions of the TRIPS agreement, particularly the general principles concerning the protection of health, the obligation to work the patent locally, anti-competitive practices, and the exclusive marketing rights conferred during the period of transit ion, will necessarily be subject to interpretation in their application. A thoughtful quote from a paper by B.K. Keayla, an expert on Patentisation: "The raw materials from India were exported and value-added finished goods at monopolistic prices were sold in Indian markets. The industry was dominated by MNCs. They were reaping enormous profits from the Indian markets. An American Senate Committee, h eaded by Senator Kefauver, stated in 1959 in its report that the prices of drugs in India were "amongst the highest in the world". The 1970 Patents Act helped the development of the industry through certain salient provisions. These included the exclusion of certain fields basic to India's economy and the well-being of the Indian people from patentability; the denial of product patents in some other important areas such as drugs and pharmaceuticals and agro-chemicals; provisio n of a shorter period of patent protection; importation not being treated as working of a patent; the compulsory licensing and licence of right to ensure working and dissemination of technologies; and the fixing of a ceiling on royalties on the sub-licen sing of patents. Thus balancing of rights and obligations and ensuring that patent monopolies are not established. Because of these features, Indian industry, during the post-1970 period after the new patent system was introduced, progressed quite satisf actorily.

The number of producers in India rose from 5,000 to 24,000, and prices came down. India should not be tripped or trapped by TRIPS. TRIPS as the West construes it is a death warrant for the lowly, the lost and the last who have no wherewithal to buy hiked high-priced medicines when hit by lethal illness.

This prefatory caveat serves as the nationalist perspective for a critique of the new legislative essay.

The patent system legally ensures the working of the patent in the country, which grants the patent rights. Imports beyond a specified period are being regarded as abuse of patent rights and for this reason the imports are being used as one of the reason s for the grant of sub-licensing to others. A system of compulsory licensing has thus been provided in national laws. Compulsory licences are granted by the national governments for upholding the public interest. In India, automatic licensing of rights has also been provided for certain products in the public interest for ensuring working of patents in a competitive environment. This right is mainly available for chemicals-based products like pharmaceuticals. As regards the term of the patent, it varies from country to country. India has had only 5 to 7 year terms for process patents for pharmaceuticals and other chemical-based products and 14 years for other products, whereas the U.S. held a uniform term of 17 years for all patents and now it has changed to 20 years because of TRIPS. The TRIPS patent system now seeks uniform patent laws for all member countries of the WTO although their economies vary vastly. According to the U.S. Supreme Court, "it is undeniably true that the limited and temporary monopoly granted to inventors was never designed for their exclusive profit or advantage, the benefit to the public or community at large was another and doubtless the primary object in granting and securing that monopoly". (Quoted in Vaughan 1956, 32). But now this objective is being totally ignored in providing a global, strong patent system in TRIPS. (Keayla)

The Patents Act 1970 has encouraged the manufacture of bulk drugs and formulations in India and the emergence of a very strong national pharmaceutical industry. The positive environment provided by the Act has resulted in much lower prices in India than elsewhere in the world. The prices are five to 30 times higher in countries which have product patent.

The above scenario is directly related to the "patent system" as practised in these countries. It is the same enterprise which is charging highly differential prices in different countries as it is possible to exploit the markets on the consideration of the extent of patent monopoly available.

More appropriately, let me draw the attention of the people of India, particularly the parliamentarians and party leaders, to the consequences of the Treaties entered into, costing us the essence of swaraj itself. The WTO is an assault on India's sovereignty. India is now Treaty-bound to lift perhaps all quantitative restrictions on imports and all non-tariff restrictions on such imports. What a pity that constitutionally we have bidden farewell to constitutional values by reducing customs duty s harply to facilitate free trade for lawful loot. Food and food products, milk and milk products (with the largest cattle population we have in the country) agricultural products, including cotton and rubber, industrial goods, manufactured elsewhere at ch eaper cost to flood our markets and starve our rural and urban people - is this socialist, Gandhian economics? Our public sector is being dismantled and our private sector will pine away and perish or be absorbed by MNCs. Small-scale industries are all o n their way to the grave. In short, we are to suffer foreign domination and are all on our way to recolonisation. This I call GATTastrophe.

Let us not worry about MNC pharmaceutical withdrawals if we do not oblige them with patent law for products. Dr. Dinesh Patel of the Indian Drug Manufacturers Association (IDMA), an expert in the field, has stated:

"Many of the well-known discoveries by international pharmaceutical companies, are mere molecular manipulations of existing patented drugs." He pointed out: "In the case of Tetracycline, an antibiotic, Pfizer had modified its molecule to create and promote a new drug Oxytetracycline. This was further developed to Doxycycline, then Doxycycline Hicalte, again by molecular manipulation. Interestingly, all these drugs enjoyed patent protection. Now, Doxycycline Hicalte is marketed at Rs.10 per tablet, while the same product is sold by Indian manufacturers at Rs.2 per tablet. This kind of monopolistic situation created by multinationals would get stronger after India goes in for product patent law. Right now, the process patent law prevalent in India has created a level playing field, ruling out monopolistic situations arising from molecular manipulations".

A global study will reveal the skulduggery of the MNCs and the Indian indigent will be forgotten by his own surrogates if product patent is granted to keep transnational corporations in exploitative good humour.

A plea in anguish to Parliament members from a layperson with concern to preserve the jurisprudence of human health for Indians: you, as proud India's humble servants, should oppose and defeat the bill before Parliament. I am sure that the two Houses, th e Health Ministry, the Prime Minister and the plural parties in our country will collectively ensure the sovereign right of Indians to battle against foreign pharmaceuticals' invasion at least to save the life and health of India's teeming millions. If y ou stand by the poor and defend the current Law of Patents 1970, that will be Parliament's finest hour! With patriotic confidence in your unreserved support, I conclude.

V.R. Krishna Iyer is a former Judge of the Supreme Court.